BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASANTE COMFORT

    MDR report key: 3599740 · Received December 4, 2013

    Report

    Report Number
    8021545-2013-00008
    Event Type
    Malfunction
    Date Received
    December 4, 2013
    Date of Event
    June 19, 2013
    Report Date
    November 29, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K120872
    Removal / Correction Number
    8021545-11/19/2013-0006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR REPORT HAS BEEN MADE SINCE THIS EVENT HAS LED TO A RECALL. THIS INCIDENT HAS ALREADY BEEN REPORTED TO THE FDA IN THE ASR REPORT FOR Q3 2013. IN NOVEMBER 2013, A VOLUNTARY PRODUCT RECALL FOR THE DEVICE WAS INITIATED AND REPORTED TO THE FDA UNDER REPORT #8021545-11/19/2013-0006. ACCORDING TO THE EVAL RESULT, WHICH IS AN EXTRACT OF THE INFO SENT TO THE FDA IN RELATION TO THE RECALL. A VISUAL INSPECTION AND A TEST FOR FLOW, LEAK AND STATIC PULL (TUBING-ASANTE CONNECTOR) WERE PERFORMED ON THE RETURNED USED DEVICE. THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR AND FOR THIS CONDITION WAS LEAKING. ALSO IN THE FLOW TEST FOUND THE TUBING CONNECTOR NEEDLE WAS CLOGGED (BY INSULIN). NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND STATIC PULL (TUBING-ASANTE CONNECTOR). THE TUBING WAS DETACHED FROM THE TUBING-ASANTE CONNECTOR 3 OUT OF 10. THE VISUAL INSPECTION, FLOW AND LEAK TESTS WERE IN ACCORDANCE WITH SPECS. UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH ASANTE SOLUTIONS, THE DISTRIBUTOR OF THE INFUSION SET. (B)(4).

    Description of Event or Problem · 1

    "PARTICIPANT REPORTED VIA EMAIL: LAST NIGHT SOME TIME WHILE I WAS SLEEPING, THE INFUSION SET TUBING PULLED OUT OF THE BLACK ADAPTER THAT CONNECTS TO THE PUMP BODY. WOKE UP AROUND 5AM WITH PRETTY HIGH BG AS A RESULT. NO HARM, NO FOUL (TOOK A SHOT AND CHANGED EVERYTHING OUT), BUT THOUGHT YOU SHOULD KNOW. I'LL EMAIL YOU A PICTURE OF THE PIECE OF TUBING THAT CAME OUT IN CASE YOU'RE INTERESTED. NO UNUSUAL ACTIVITY LAST NIGHT. I USUALLY CLIP THE PUMP TO MY SHORTS, BUT IT OFTEN UNCLIPS SOMETIME DURING THE NIGHT. HAVEN'T HAD A PROBLEM BEFORE (15+ YEARS) WITH TUBE BREAKING OFF FROM THE CONNECTOR. THIS WAS A COMFORT INFUSION SET LOT 230124. DATE OF INCIDENT: (B)(6) 2013 - NO MEDICAL ATTENTION NEEDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629510 ASANTE COMFORT ASANTE COMFORT FPA UNOMEDICAL A/S 4143-5 230124

    Patients

    Seq Age Sex Outcome Treatment
    1